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O estudo clínico NCT03184545 para Síndrome da dor patelofemoral está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome

Recrutando
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O estudo clínico NCT03184545 procura avaliar o tratamento para Síndrome da dor patelofemoral. Este é um ensaio intervencionista de Fase III. Seu status atual é: recrutando. O estudo começou em 24 de julho de 2017 e pretende incluir 92 participantes. Coordenado por Northwell Health e deve ser concluído em 1 de junho de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de dezembro de 2024.
Resumo
The purpose of study is to evaluate the efficacy of the electrical muscle stimulation (EMS) device in patients with patellofemoral pain known as anterior knee pain. Usual treatment for it is physical therapy (PT). We want to evaluate and see if adding the electrical muscle stimulation will fasten the recovery and improved outcome in patellofemoral pain syndrome. Half of participants will receive EMS and PT while other half will receive PT only.
Descrição detalhada
The patellofemoral pain syndrome also known as anterior knee pain is a common entity in young athletic population. In patellofemoral knee syndrome, one of the theory is that the vastus medialis obliquus muscle is weak. To strengthen the muscle, physical therapy exercises are commonly used. This study evaluates addition of the electrical muscle stimulation device.The electrical muscle stimulation device "Flex MT Plus" (Electrostim Medical Services Inc. Tampa, FL) is a FDA approved device and has been used in knee for other conditions like treating for weakness associated with knee injuries or after knee surgeries. It has shown to improve the outcomes in above mentioned conditions. Its efficacy has been tested in patellofemoral pain syndrome but in smaller sample size. We intend to test it in larger sample size patient population.

Bily et al (2008) (reference #1) published their results on patellofemoral pain syndrome comparing EMS +PT to PT only and found that overall significant improvement in outcome score in all patients but when compared between the groups there was no difference. But there sample size was 19 patients in each group. Small sample size was one of the limitation of their study. We intend to collect 46 patients in each group to find significant difference based on power analysis.

Título oficial

A Prospective Randomized Study Comparing the Outcome of Electrical Stimulation of Vastus Medialis Obliquus Muscle and Physical Therapy Vs Only Physical Therapy but No Electrical Stimulation in Patients with Patellofemoral Pain Syndrome

Condições
Síndrome da dor patelofemoral
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
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Outros IDs do estudo
  • 16-726
Número NCT
Data de início (real)
2017-07-24
Última atualização postada
2024-12-03
Data de conclusão (estimada)
2027-06
Inscrição (estimada)
92
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Recrutando
Palavras-chave
anterior knee pain
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Simples-cego
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalEMS and PT
Group 1: Electrical Muscle stimulation (EMS) and Physical therapy (PT).
EMS
The EMS device Flex MT Plus (Electrostim Medical Services Inc. Tampa, FL) is a neuromuscular stimulator. It is approved by the FDA. The Electrical muscle stimulation (EMS) applied to vastus medialis obliquus (VMO) muscle for 20 minutes, 3 times daily and it would be 5 times a week for 12 weeks at 40 Hz. The pulse duration will be 0.26ms, at 5 seconds on and 10 seconds off.
Fisioterapia
Standard physical therapy exercises
Comparador ativoOnly PT
Group 2: Only Physical therapy (PT).
Fisioterapia
Standard physical therapy exercises
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Kujala patellofemoral score.
Assessment will be done at each visit (pre-treatment, post-start treatment 3 weeks,, 6 weeks, 12 weeks, 6 months and 12 months) based on Kujala patellofemoral score. The Kujala score assesses following points: Limp, support, walking, stairs, squatting,running, jumping, prolong sitting with knee flexed,pain,swelling,abnormal painful kneecap movements, atrophy of thigh and flexion deficiency. Repeated measures linear regression models will be used to compare the two treatment arms with respect to knee function, pain score, and muscle strength from baseline to 12 months. Total duration of study is two years. We intend finish enrolling 92 patients by the end of one year after start of study. But each patient will be followed for total 12 months period. If any patient enrolled at 1 year mark after start of study , he will be followed for one year.
2 years. Total duration of study is two years. But each patient will be followed for total 12 months after enrollment. If any patient enrolled at 1 year mark after start of study , he will be followed for one year. So total duration of study is 2 years.
Visual analog pain scale (VAS) pain scale during activities of life
VAS scale of 1-10 will be used to evaluate knee pain. 1 being mild and 10 being worst.
2 years
Isometric strength measurement of knee
Isometric strength will be measured using dynamo-meter.
2 years
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Secondary outcome measure would be how many return to sports activity.
Secondary outcome assessment will be to see how many in EMS+PT group and how many in PT group returned to their previous activity level of sports without any pain after completion of treatment.
2 years
At what point of time they returned to their sports activity
It will be also noted and compared between the groups at what time period after the start of treatment they returned to their regular sports activities. We hypothesize that EMS group might return early.
2 years
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
  • Bilateral/unilateral anterior knee pain for more than 3 moths
  • Age of patient 18 to 40 years
  • At least 3 of the 4 following criteria present: pain associated with prolonged sitting with knees bend, pain with going downstairs, kneeling and squatting or sports activities
  • No h/o injury
  • No h/o surgery to the knee

  • H/o patellar dislocation or subluxation
  • Associated bursitis, tendinitis in periarticular area
  • Ligamentous problems
  • Intra-articular pathology
  • Pregnancy (patient reported pregnancy, in case of doubt patient will be referred to their OBG/GYN physician to exclude the pregnancy)
  • H/o knee surgery
  • Oral or intraarticular administration of steroid medication with in last 3 months
  • Patients with implanted devices like pacemaker
Northwell Health logoNorthwell Health
Responsável pelo estudo
Leon Popovitz, Investigador principal, Orthopaedic Surgeon, Northwell Health
Contato central do estudo
Contato: Leon Popovitz, MD, 2127594553, [email protected]
Contato: Rupesh Tarwala, MD, 2132915282, [email protected]
1 Locais do estudo em 1 países

New York

New York Bone and Joint Specialists, New York, New York, 10019, United States
Leon Popovitz, MD, Contato, 2127594553, [email protected]
Rupesh Tarwala, MD, Contato, 2127594553, [email protected]
Recrutando